Asthma
Conditions
Keywords
Bronchial challenge test, Hyperreactivity, PD20 for metacholine, Daily magnesium supplement
Brief summary
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. The aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.
Interventions
DIETARY_SUPPLEMENTMagnesium supplement (magnesium hydroxide/ -oxide)
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
DIETARY_SUPPLEMENTPlacebo
3 placebo-tablets daily for 12 weeks
Sponsors
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (PD20\<1000 microgram
Exclusion criteria
* Se-Mg \> 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD20 for metacholine | Two years | Bronchial hyperreactivity is expressed by the dose of inhaled metacholine necessary to achieve a decline of 20 % in FEV1 (Bronchial challenge test). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impulse Oscillometry for measurement of pulmonary impedance | Two years | A characteristic feature of Impulse Oscillometry is that pulmonary impedance is not derived from the respiratory signals but from the pressure-flow relationship of artificial impulse-shaped test signals which are produced by an external generator. The advantage of artificial test signals is the incomparably higher frequency contents with a relatively high consistency as far as frequency range and amplitude are concerned, so that a thorough differentiation of pulmonary function is possible. |
Countries
Denmark
Outcome results
None listed